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A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer (CAN-STAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159155
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE November 7, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date August 11, 2020
Estimated Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
Disease Free Survival Rate [ Time Frame: 3 years ]
Time from random assignment until disease recurrence or death
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • Overall Survival Rate [ Time Frame: 5 years ]
    Time from enrollment until death.
  • Number Adverse Events Experienced [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer
Official Title  ICMJE Canadian Multi-arm Multi-stage Randomized Controlled Trial Assessing Front Line Treatment in Serous or p53 Mutant Endometrial Cancer
Brief Summary

This a phase II and III study whose purpose is to compare how long various treatment regimens can keep the cancer from worsening or coming back in people with serous or p53 abnormal endometrial cancer.

The study is divided into three cohorts: Early stage cohort, advanced stage cohort, and exploratory cohort. Each cohort will have different arms to examine different treatment regimens to determine the best regimen for each cohort.

The study will enroll participants into the early stage cohort at this time. The early stage cohort will compare the following treatments after standard of care surgery:

  • Adjuvant chemotherapy with carboplatin and paclitaxel alone
  • Adjuvant radiation therapy and chemotherapy with cisplatin, followed by chemotherapy with carboplatin and paclitaxel.
Detailed Description

There is currently no standard or usual treatment for serous or p53 abnormal endometrial cancer after standard surgery. Additional treatment may sometimes be given after the main treatment in hopes of preventing the cancer from worsening or coming back (called adjuvant therapy).

It is not fully know whether adjuvant therapy after surgery is useful in early stage endometrial cancer. It is also not known what the best adjuvant therapy after surgery is. The most commonly given adjuvant therapy is chemotherapy with carboplatin and paclitaxel. Sometimes, chemotherapy and radiation therapy may be given. There is not enough information available as to how useful adjuvant therapy is and what the most useful type of treatment is. This study will look at adjuvant chemotherapy alone compared with adjuvant radiation therapy and chemotherapy, after standard of care surgery, in patients with serous or p53 abnormal endometrial cancer.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometrial Cancer
  • Serous Tumor
  • P53 Mutation
Intervention  ICMJE
  • Drug: Cisplatin
    Chemotherapy drug given by vein.
  • Radiation: External Beam Radiation
    Radiation therapy given outside the patient to a particular part of the body.
  • Drug: Carboplatin
    Chemotherapy drug given by vein.
  • Drug: Paclitaxel
    Chemotherapy drug given by vein.
Study Arms  ICMJE
  • Experimental: Early Stage Cohort - Arm A
    Carboplatin, intravenously, once every 3 weeks for 6 cycles Paclitaxel, intravenously, once every 3 weeks for 6 cycles
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: Early Stage Cohort - Arm B1
    • External beam radiotherapy, 5 days per week, for 4-5 weeks
    • Cisplatin intravenously, on the first and fourth week of radiotherapy.
    • Brachytherapy will be given if needed Then
    • Carboplatin, intravenously, once every 3 weeks for 4 cycles
    • Paclitaxel, intravenously, once every 3 weeks for 4 cycles
    Interventions:
    • Drug: Cisplatin
    • Radiation: External Beam Radiation
    • Drug: Carboplatin
    • Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2026
Estimated Primary Completion Date September 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with pure serous endometrial carcinoma will be included. Other histotypes (endometrioid and clear cell) with abnormal/mutant-type p53 is acceptable.
  • Local TP53 results must be available for Central review.
  • Patients diagnosed with stage I, II tumors will be enrolled in the early stage cohort.
  • Patients suitable for an optimal surgery.
  • Eastern Cooperative Group (ECOG) performance status ≤ 2 (Karnofsky ≥60%).
  • Life expectancy of greater than 3 months.
  • Patients must have archival tissue available. If no tissue is available, tumor biopsy will be mandatory.
  • Ability to understand and willing to sign a written informed consent document.
  • Within 8 days of the proposed start of treatment, patients must have normal organ and marrow function.
  • Women of child-bearing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication.

Exclusion Criteria:

  • Patients who have previously received chemotherapy or hormonal treatment for endometrial cancer.
  • Any other condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
  • Mixed serous tumours or tumors with subclonal mutant-type p53 staining. Endometrial carcinosarcoma will also be excluded.
  • Patients being treated with radiotherapy within 4 weeks, or palliative radiotherapy encompassing >20% of the bone marrow within 1 week of starting study treatment.
  • Patients who are receiving any other investigational agents.
  • Patients with known brain metastases are excluded from participation unless stable for greater than 1 month following definitive treatment.
  • Patients with evidence of fistula will be excluded.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
  • Uncontrolled inter-current illness that would limit compliance with study requirements.
  • Pregnant women are excluded.
  • Known HIV-positive patients on antiretroviral therapy or active Hepatitis B or C are ineligible.
  • Patients with a history of other malignancy ≤ 3 years prior to registration, with exceptions.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amit Oza, MD 416-946-2818 amit.oza@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04159155
Other Study ID Numbers  ICMJE CAN-STAMP
CAPCR 19-6178 ( Other Identifier: Princess Margaret Cancer Centre )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amit Oza, MD Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP